CLINICAL TRIAL

Sitagliptin added to stable insulin therapy with or without metformin in Chinese patients with type 2 diabetes R Ravi Shankar1*, Yuqian Bao2, Ping Han3, Ji Hu4, Jianhua Ma5, Yongde Peng6, Fan Wu7†, Lei Xu1, Samuel S Engel1, Weiping Jia2 1

Merck & Co., Inc., Kenilworth, New Jersey, USA, 2Shanghai Jiao Tong University Affiliated Sixth People’s Hospital, Shanghai, 3Shengjing Hospital of China Medical University, Shenyang, 4The Second Affiliated Hospital of Soochow University, Suzhou, 5Nanjing First Hospital Affiliated to Nanjing Medical University, Nanjing, 6Shanghai First People’s Hospital affiliated to Shanghai Jiaotong University, Shanghai, and 7MSD China, Beijing, China

Keywords Insulin, Sitagliptin, Type 2 diabetes mellitus *Correspondence R Ravi Shankar Tel: +1-732-594-3046 Fax: +1-732-594-1880 E-mail address: [email protected] J Diabetes Investig 2017; 8: 321–329 doi: 10.1111/jdi.12585 Clinical Trial Registry ClinicalTrials.gov NCT01590797

ABSTRACT Introduction: We evaluated the tolerability and efficacy of the addition of sitagliptin in Chinese patients with type 2 diabetes mellitus receiving stable insulin therapy alone or in combination with metformin. Materials and Methods: A total of 467 patients with inadequate glycemic control on insulin (glycated hemoglobin [HbA1c] ≥7.5% and ≤11%) were randomized 1:1 to receive sitagliptin 100 mg once daily or a matching placebo for 24 weeks. Randomization was stratified based on metformin use (on or not on metformin) and type of insulin (premixed vs intermediate-/long-acting) at screening. The primary end-point was the change from baseline at week 24 in HbA1c. Results: The addition of sitagliptin led to a significantly (P < 0.001) greater week 24 HbA1c reduction (0.7%) compared with the reduction (0.3%) with placebo. A significantly (P = 0.013) greater proportion of patients taking sitagliptin (16%) had an HbA1c of 240 mg/dL (>13.32 mmol/L) after week 6 to week 12, and FPG consistently >200 mg/dL (>11.10 mmol/L) after week 12. The investigator used his/her clinical judgment to manage the adjustment in insulin dose(s) for glycemic rescue. Downtitration of insulin was to be carried out if a patient had an unexplained (i.e., not explained by a missed meal, excessive physical activity etc.) hypoglycemic episode (symptomatic or asymptomatic) or the patient was considered at risk of hypoglycemia based on the investigator’s review of the patient’s self-monitored blood glucose values. If any of these criteria were met, the investigator could reduce the dose of insulin by a minimum of 2–4 IU/day until the patient was no longer judged by the investigator to be at risk for hypoglycemia. If the patient continued to experience hypoglycemic episodes on this lowered dose, they were to be evaluated for discontinuation from the study. This study was carried out in accordance with the Declaration of Helsinki and good clinical practice, and was approved by the appropriate institutional review boards and regulatory agencies. All patients provided written informed consent before participating in the trial. Efficacy end-points

The primary efficacy end-point was change from baseline at week 24 in HbA1c. Secondary efficacy end-points included the proportion of patients with an HbA1c

Sitagliptin added to stable insulin therapy with or without metformin in Chinese patients with type 2 diabetes.

We evaluated the tolerability and efficacy of the addition of sitagliptin in Chinese patients with type 2 diabetes mellitus receiving stable insulin t...
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